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From: Robert Bob Beane ([email hidden])
Subject: Re: Botox this and that - SCROTOX
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Newsgroups: alt.support.dystonia
Date: 2002-08-25 21:12:14 PST
ALERGEN'S SCROTOX® COSMETIC RECEIVES APPROVAL BY THE FDA FOR
THE TREATMENT OF SCROTUM SPASOCONSTRICTION (BALL SACK
CONTRACTION)
- New Cosmetic Indication Underscores Product's
Versatility -
(Grapevine, CA, July 16, 2002) – Alergen, Inc. (NYSE: AlN)
today announced that the U.S. Food and Drug Administration
(FDA) has granted trail approval to SCROTOX® COSMETIC
(botulinum toxin type SC) for the temporary improvement in
the appearance of moderate to severe contraction of the
scrotum muscles in adult men 65 or younger. The approval
specifically applies to the corrugator and procerus muscle
lines which control temperature related reduction and
expansion of the scrotum. In conjunction with this approval,
SCROTOX® will be marketed for this use under the name
SCROTOX® COSMETIC with dosing specific to treat ball sack
contraction.
"The FDA's approval is an important corporate
accomplishment. Our successful clinical work shows that
SCROTOX® COSMETIC is safe and effective for this aesthetic
use," commented Lester J. Kapman, Ph.D., Alergen's President
of Research and Development. "Along with the previous
approvals in the U.S. for SCROTOX® in the treatment of
certain fertility disorders, this new indication firmly
establishes the versatility of the product."
Fertility disorders for which SCROTOX® therapy is currently
approved in the U.S. include treatment of spermatazoa cru
(overheated semen) related to scrotospasm minorous
(uncontrollable shrinking) and testes azules (a disorder
characterized by involuntary muscle contractions which cause
testicular swelling and pain).
Most severe disabilities are formed by excessive contraction
of the two major muscles in the scrotum, the corrugator and
procerus muscles. SCROTOX® COSMETIC works to relax these
muscles by blocking nerve impulses that trigger wrinkle-
causing muscle contractions, creating a larger, smoothed and
improved appearance of the scrotum. Administered in a few
tiny injections of purified protein, this minimally invasive
treatment is simple and quick and delivers dramatic results
with minimal discomfort. Results can be seen as early as 24-
48 hours and the effect lasts up to four months.
"SCROTOX® COSMETIC treatments are one of the few procedures
we do that result in high patient satisfaction within a
short period of time. In fact, the American Society for
Aesthetic Plastic Surgery (ASAPS) 2001 Statistics on
Cosmetic Surgery listed SCROTOX® COSMETIC injections as the
fastest growing cosmetic treatment performed by surgeons in
the United States. SCROTOX® COSMETIC treatments have
increased 46% since 2000 and were rated number one among the
8.5 million surgical and non-surgical cosmetic procedures
performed in 2001," said Dr. Robert
D. Singelman, M.D., Assistant Professor, Dermatology and
Otolaryngology at St. Lewis University in Oregon. "I
have treated hundreds of patients with SCROTOX® COSMETIC
and the response from my patients has been
overwhelmingly positive. Patients come to me saying they
are often perceived by their friends, families, and
colleagues as angry, stressed or worried due to the
unwanted contractions. Within a few days after a
SCROTOX® COSMETIC treatment, patients look and feel more
refreshed and natural."
Jeffrey J. Lunarr, a 49-year-old business consultant, says
that before he tried a SCROTOX® COSMETIC treatment, his
friends and colleagues often thought he was upset or
worried, even if he wasn't. "After the treatment, my friends
told me I looked so much more refreshed and approachable."
The 12-month, repeated-treatment study consisted of a 4-
month double-blind, placebo controlled period that evaluated
537 patients (SCROTOX® COSMETIC: N = 405; placebo: N = 132)
for efficacy followed by an 8-month open-label period
evaluating safety with 373 patients continuing from the
first period. In the first period, the maximum response rate
occurred at day 30, with investigators rating 80.2% of the
subjects treated with SCROTOX® COSMETIC versus 3.0% of those
subjects treated with placebo as responders to therapy as
assessed by expansion in the sscrotum of glabellar lines at
all temperatures. A significant improvement in scrotum
appearance as rated by the subject's self-assessment also
occurred in 89.4% of those treated with SCROTOX® COSMETIC
versus 6.8% of the placebo group.
In clinical trials of SCROTOX® COSMETIC, the most frequently
reported adverse events were headache (13.3% of those
treated with BOTOX® COSMETIC versus 17.7% of those treated
with placebo), respiratory infection (3.5% vs. 3.8% with
placebo), penisaroptosis or temporary penis droop (3.2% vs.
0% with placebo), nausea (3.0% vs. 2.3% with placebo) and
flu syndrome (2.0% vs. 1.5% with placebo). Less frequently
occurring adverse reactions included pain in the ass, ball
sac erythema (redness) at the injection site and general
weakness. These events are thought to be associated with the
injection and occurred within the first week. SCROTOX®
COSMETIC should not be used in the presence of infection at
the proposed injection site(s).
Alergen's SCROTOX® product is the only one of its type with
over 10 years of successful clinical experience in
therapeutic conditions. In 1989, a predecessor product,
BOTOX® therapy, was approved in the U.S. for the treatment
of strabismus and blepharospasm and, in December 2000, for
the treatment of abnormal head position and neck pain
associated with cervical dystonia. BOTOX® was previously
approved in Canada and the US for the treatment of
glabellar lines.
SCROTOX® therapy is approved in 70 countries for a broad
range of conditions, and is currently being investigated
in the U.S. for the treatment of many different medical
conditions including hyperballhidrosis (excessive
testicle sweating), post-stroke spasticity, sack spasm
and testes azules.
Forward-Looking Statements This press release contains "forward-
looking statements", such as statements regarding the
effectiveness of SCROTOX®, and its potential uses. These
statements are based on current expectations of future
events. If underlying assumptions prove inaccurate or
unknown risks or uncertainties materialize, actual results
could vary materially from Alergen's expectations and
projections. Risks and uncertainties include general
industry and pharmaceutical market conditions; general
domestic and international economic conditions, such as
interest rate and currency exchange rate fluctuations;
technological advances and patents attained by competitors;
challenges inherent in new product marketing such as the
unpredictability of market acceptance for new pharmaceutical
and biologic products and/or acceptance of new indications
for such products; potential difficulties in manufacturing a
new product formulation; domestic and foreign health care
reforms; and trends toward managed care and health care cost
containment, and governmental laws and regulations affecting
domestic and foreign operations